The FDA cleared GlaxoSmithKline’s BCMA-targeting antibody–drug conjugate Blenrep to return to the U.S. market with a restricted label. The agency approved Blenrep for use in combination with Velcade (bortezomib) for patients whose multiple myeloma has relapsed after at least two prior lines of therapy, rather than the broader indications GSK sought. GSK pursued U.S. relaunch after pulling the drug in 2022 following a failed confirmatory trial and eye‑toxicity concerns. The FDA’s decision reflects mixed judgment: it accepted efficacy data from the DREAMM‑7 regimen but rejected some other combinations and narrower-line use, leaving GSK with a limited commercial pathway in the U.S. Investors and clinicians will watch real‑world uptake and labeling details closely; Blenrep remains one of the earliest BCMA‑targeted antibody programs and its reintroduction tests how regulators balance safety signals, competing BCMA modalities, and unmet need in relapsed myeloma.